N/A
N=31
Mifepristone in Refractory Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00186056 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Hamilton Depression Rating Scale — 18.75; 19.68 units on a scale — p=<.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mifepristone (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale |
18.75; 19.68 | <.26 |
Summary
The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.
Eligibility Criteria
Inclusion Criteria::
- 21-item HAM-D score of 20 or above.
- If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
- At least 2 failed antidepressant medication trials of adequate dose and duration.
- Between 18 and 75 years of age.
- Not currently pregnant or trying to become pregnant. Exclusion Criteria:-History of schizophrenia or other psychotic disorders.
- Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.
- History of vagus nerve stimulation treatment.
- No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
- Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.
- Previous allergic reaction to mifepristone or drugs of similar chemical structure.
Data sourced from ClinicalTrials.gov (NCT00186056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.